Table 2

Manufacturing consistency and epitope specific antigenicity testing of multiple lots of HPV16 VLPs-pre- and post-D/R treatment.

Lot No.a

Epitope specific antigenicity (Relative IC50)


H16.V5

H16.E70

H263.A2

H16.J4

pre-D/R

C1

0.54

0.30

0.53

6.73

C2(pre-)

0.51

0.31

0.51

5.51

C3(pre-)

0.48

0.27

0.46

5.24

Ave. (n = 3)

0.51 ± 0.03

0.29 ± 0.02

0.50 ± 0.03

5.83 ± 0.80

post-D/R

C2

1.17

1.33

1.11

0.43

C3

0.89

0.94

0.95

1.05

C4

0.97

0.83

1.00

0.94

C5b

1.00

1.00

1.00

1.00

K1

1.01

1.08

0.88

0.91

K2

0.76

0.83

0.82

0.73

K3

0.93

0.95

0.92

0.70

K4

0.94

0.95

0.92

0.88

Ave. (n = 8)

0.96 ± 0.10

0.99 ± 0.07

0.95 ± 0.06

0.83 ± 0.10


Solution antigenicity was assessed with a panel of four anti-HPV 16 L1 mAbs in a competitive FL-ELISA. Data from three lots of pre-D/R and eight lots of post-D/R are presented. Each reported relative IC50 value is an averaged value from three independent measurements on three different plates with a typical RSD% of 12-15%

a Developmental lots during clinical testing stage ("C lots") and commercial lots ("K Lots")-see also Figure 2. Once the reassembly process was developed, only the post-D/R lots were tested clinically. Therefore, no clinical experience was gained with C2-pre-D/R and C3-pre-D/R, and these two lots are excluded from the analysis and plotting for "clinical experience" (Figure 2)

b This lot was used as the reference lot in the relative antigenicity assay (or relative IC50). Lot C5 was used as the reference lot for all antigenicity testing and it was tested on every plate along with other test lots

Zhao et al. Virology Journal 2012 9:52   doi:10.1186/1743-422X-9-52

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